Five-year Survival Rate For Nivolumab-treated Advanced Lung Cancer Patients Much Higher Than Historical Rate

Excerpt:

“Treatment with the immune checkpoint inhibitor nivolumab (Opdivo) yielded durable responses in some patients with advanced non-small cell lung cancer (NSCLC), with a five-year survival rate of 16 percent, according to data from a phase I clincal trial presented here at the AACR Annual Meeting 2017, April 1-5.

“According to the National Cancer Institute’s SEER data, five-year survival rate for patients with advanced lung and bronchus cancer is 4.3 percent, and for those with advanced NSCLC, it is 4.9 percent.

” ‘This is the first report of the long-term survival rate in patients with metastatic NSCLC treated with an immune checkpoint inhibitor. Our study results show that for a small subset of patients, immunotherapy can work for a very long time,’ said Julie Brahmer, MD, associate professor of oncology at the Bloomberg~Kimmel Institute for Cancer Immunotherapy at Johns Hopkins.”

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Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) and Opdivo Monotherapy Significantly Improved Overall Survival Versus Yervoy Alone in Patients with Previously Untreated Advanced Melanoma

Excerpt:

Bristol-Myers Squibb Company (NYSE:BMY) today announced the first overall survival (OS) data from the Phase 3 CheckMate -067 clinical trial. With a minimum follow-up of 28 months, the median OS had not yet been reached in either of the two Opdivo treatment groups and was 20 months for the Yervoy monotherapy group (95% CI: 17.1-24.6). Opdivo in combination with Yervoy and as a monotherapy reduced the risk of death 45% [hazard ratio (HR) 0.55; 95% CI: 0.42-0.72; P<0.0001] and 37% (HR 0.63; 95% CI: 0.48-0.81; P<0.0001), respectively, compared with Yervoy alone. The two-year OS rates were 64% for the Opdivo plus Yervoy combination, 59% for Opdivo alone and 45% for Yervoy alone. Results will be presented today in the press program and an oral presentation during the Update, Novel Indication, and New Immuno-oncology Clinical Trials session from 3:35 to 3:50 p.m. ET (Late-Breaking Abstract CT075) at the American Association for Cancer Research Meeting 2017 in Washington, D.C.”

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Clinical Trials Test Treatments for High-Grade Brain Tumors


With a few exceptions, glioblastoma (GBM) remains largely incurable, and the U.S. Food and Drug Administration (FDA) has approved few treatments for the disease. Surgery (when feasible), radiation, and temozolomide are used in most patients. But even if a newly diagnosed tumor can be surgically excised, recurrences are too common.

In this blog post, I simply list some of the new treatments available in clinical trials for GBM and other high-grade brain tumors. Only drugs that have at least some preliminary results of activity are included, and the list is not meant to be fully comprehensive. The interested reader can judge for herself what might be of interest, keeping in mind that no single treatment is suitable or will work for all GBM patients. Continue reading…


FDA Grants Fast Track Designation to ImmunoPulse IL-12 for Melanoma

Excerpt:

“The FDA granted fast track designation to ImmunoPulse IL-12 for the treatment of metastatic melanoma that progressed during therapy with pembrolizumab or nivolumab.

“ImmunoPulse IL-12 (OncoSec Medical) is an intratumoral anticancer gene therapy that expresses interleukin-12 (IL-12).

“ ‘With the number of melanoma patients now being treated with either pembrolizumab (Keytruda, Merck) or nivolumab (Opdivo, Bristol Myers Squibb) in either the first- or second-line settings, there will be an increasing number of patients who will not respond to therapy,’ Punit Dhillon, president and CEO of OncoSec, said in a company-issued press release. ‘Thus, there is a clear need for treatments that can rescue these patients and help them benefit from these immunotherapies.’ ”

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Super Patient: Peter Fortenbaugh Faces the Uncertainty of Pioneering Melanoma Treatment


In spring of 2014, Peter Fortenbaugh noticed what appeared to be a tick that had bitten his lower calf. “It turned out not to be a tick, but it didn’t really go away,” he says.

The spot began to grow and bulge, and in October, Peter showed it to his primary care doctor, who referred him to a dermatologist to remove it. At the time, Peter recalls, it did not occur to him that the growth could be serious.

“I was actually very concerned about skin cancer because I spent a lot of time out in the sun sailing,” Peter says. “I put on a tremendous amount of sunscreen and protection, but never on my legs…I never connected the dots.”

However, a biopsy of the growth came back positive for melanoma. Peter, who lives in Palo Alto, California, with his wife and three children, immediately reached out to several doctors in the San Francisco Bay Area, and all had the same advice: “Take it out, take a biopsy.” Continue reading…


Concerns That Rosy Direct-To-Consumer Ads Hype Cancer Drugs To Vulnerable Patients

Excerpt:

“A few weeks ago, I was watching veg-out TV, quietly wondering to myself how a show called ‘Pure Genius’ could be so darned dumb.

“Then a commercial break added a new sort of mystification: A long, vivid ad touted the cancer drug Opdivo, a form of immunotherapy — an exciting new type of treatment that harnesses the body’s own immune system — for lung cancer.

“Lung cancer is the biggest cancer killer, so, in this anomalous country that allows direct-to-consumer drug ads, it was no surprise to see a lung cancer ad on network TV.”

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Frontline Immunotherapy Combo Setbacks Strike NSCLC

Excerpt:

“Bristol-Myers Squibb (BMS) and AstraZeneca have each announced separate delays in the development of PD-1 and CTLA-4 inhibitor combinations as first-line therapies for patients with advanced or metastatic non–small cell lung cancer (NSCLC), according to statements from each of the companies.

“In its statement, BMS noted that it would not be pursuing an accelerated approval for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) as a frontline therapy for NSCLC. Instead, the company plans to delay the submission of data to the FDA until findings from a phase III study are available, most likely from the phase III CheckMate-227 trial.”

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Bristol Won’t Seek Faster Opdivo/Yervoy Lung Cancer Approval

Excerpt:

“Bristol-Myers Squibb Co on Thursday said it has decided not to seek accelerated U.S. approval for a combination of its two immunotherapy drugs as an initial treatment for lung cancer.

“Shares of Bristol, which closed at $55.49 on the New York Stock Exchange, were down 6.2 percent at $52.08 after hours.

“The pharmaceutical company cited ‘a review of data available at this time’ for the decision to hold off on filing for Food and Drug Administration approval of the combination of its cancer drugs Opdivo and Yervoy.”

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Cancers Evade Immunotherapy by ‘Discarding the Evidence’ of Tumor-Specific Mutations

Excerpt:

“Results of an initial study of tumors from patients with lung cancer or head and neck cancer suggest that the widespread acquired resistance to immunotherapy drugs known as checkpoint inhibitors may be due to the elimination of certain genetic mutations needed to enable the immune system to recognize and attack malignant cells. The study, conducted by researchers on the cells of five of their patients treated at the Johns Hopkins Kimmel Cancer Center, is described online Dec. 28 in Cancer Discovery.”

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